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April 10, 2005

Doctors Take Issue With Bextra Withdrawal

by Sam Savage

Some believe the decision to use the drug should stay with physicians

HealthDay News -- Medical professionals expressed surprise and concern at Thursday's FDA announcement that the prescription painkiller Bextra would be withdrawn from the market, and that a host of other effective analgesics will now come with tough "black box" labeling warning of their potential cardiovascular and gastrointestinal risks.

As physicians lose another tool in helping patients fight pain, some practitioners wondered if the decision to prescribe Bextra would be better left to individual doctors instead of a federal agency.

"The FDA is taking away doctor-patient decision-making," said Dr. Gerard Varlotta, director of sports rehabilitation at New York University Medical Center in New York City. "I think they could allow Bextra to be sold with warnings and it would then be a doctor-patient decision. We have warning labels on everything, even plastic bags."

"I'm not second-guessing the FDA... but, by the same token, the average consumer is going to be confused and the average physician, myself included, is somewhat confused," added Dr. David A. Peura, professor of internal medicine and associate chief of gastroenterology at the University of Virginia Medical School and incoming president of the American Gastroenterological Association.

Less than two months after expert advisory panels recommended that the cox-2 drugs Celebrex and Bextra stay on the market -- albeit with enhanced warnings -- the U.S. Food and Drug Administration on Thursday asked Pfizer Inc. to remove Bextra from the market. The agency also mandated strong black-box warning labels for Pfizers's Celebrex, the only drug in the cox-2 class still available to consumers.

Traditional nonsteroidal anti-inflammatory drugs (NSAIDs) -- such as prescription dosages of naproxen and prescription dosages of ibuprofen -- will also adopt these tough new warnings.

In addition, the agency took the step of asking all manufacturers of over-the-counter NSAIDs such as Advil, Aleve, Motrin and generic ibuprofen to revise their labeling to include more specific information about cardiovascular and gastrointestinal risks and the risk for a rare but potentially fatal skin reaction.

The cox-2 inhibitors, a subclass of the group of NSAIDs medications, have been embroiled in controversy since Merck & Co. voluntarily withdrew its blockbuster drug Vioxx from the market last September. That action was prompted by reports of cardiovascular side effects. Since then, all three cox-2 inhibitors came under scrutiny, culminating in a highly visible joint meeting of two FDA advisory committees in mid-February.

The FDA said Thursday that it would consider "carefully" any proposal from Merck for putting Vioxx back on the market.

The cox-2 inhibitors were originally developed to provide pain relief without the gastrointestinal side effects associated with traditional NSAIDs, such as aspirin or ibuprofen.

Life is now going to be more complicated for patients requiring treatment with NSAIDs, Peura said. Depending on their risk for heart and gastrointestinal problems, they could be on several drugs at once, he said.

For example, a person with cardiovascular risk who needs Celebrex may have to take aspirin to counteract potential heart risks. But then aspirin reintroduces the risk of gastrointestinal problems, Peura explained. In that case, a proton pump inhibitor, such as Prevacid or Nexium, may be required, as well, he said.

"Whether patients can comply with all of that, or whether physicians will do that, or whether the pharmacy-benefits folks will allow that, remains to be seen," Peura said.

Some doctors felt the risk from cox-2 inhibitors was minimal, he added. For one thing, the cardiovascular side effects were seen in much higher doses than are normally prescribed and for longer durations of time, he said.

Varlotta said he has patients who would still like to use Bextra or Vioxx. One, an 82-year-old man with a heart stent and pacemaker, went off Bextra when its cardiovascular risks were first revealed. His quality of life soon became so bad, however, that he asked to be put back on the pain reliever.

"I don't care if I live six months longer or not," Varlotta quoted the patient as saying. Last week, Varlotta provided him with another Bextra prescription -- his last, given the drug's withdrawal.

For other patients, it may be a different kind of trade-off. Varlotta said he recently saw a woman who was morbidly obese and experiencing pain. He told her she needed to lose 100 pounds or she would continue experiencing the pain. The decision that doctors in his situation must make is between "the [cardiac] risk of medication to help her exercise or the risk of being obese," Varlotta said.

"It's a balancing act and the FDA has tilted the teeter-totter in handcuffing doctors," he said. "I don't think they should do that. It's an individual decision."